Thousands of diabetics rely on insulin pumps to help control their diabetes and maintain their health. An alternative to insulin injections, insulin pumps are pager-size devices that work by delivering preprogrammed and user-adjusted doses of insulin into the user’s body. Unfortunately, a popular insulin pump – the Medtronic Paradigm Insulin Infusion pump – may be causing users more harm than good.
On Friday, July 12, 2013, the U.S. Food and Drug Administration (FDA) announced the recall of a Medtronic Inc. product used with the company’s Paradigm insulin pump, saying the product could result in diabetes patients getting too much — or too little — insulin.
The recall involves 37 models of Medtronic’s Paradigm Insulin Infusion Sets. According to the Star Tribune, Medtronic sent an urgent safety notification to doctors and other health care professionals last month indicating that if insulin or other fluids come into contact with the inside of the device’s tubing connectors, the vents that allow the pump to prime could become temporarily blocked, which could result in the patient receiving too little or too much insulin.
A Medtronic insulin pump recall is a Class I recall, which means that “there is a reasonable chance that they could cause serious health problems or death.” A Medtronic spokeswoman indicated that the company has received reports of hospitalizations that may be related to the problem, but the cases have not been confirmed.
According to the Star Tribune, customers generally replace their infusion sets every two to three days, but they could have several months’ worth of supplies on hand. Affected models were manufactured from October 2001 through June 2013 and distributed from December 2001 through June 2013. A list of affected models can be found online on the FDA’s website. Patients also can contact Medtronic’s 24-hour helpline at 1-888-204-7616.
Medtronic has said there is no need to replace the infusion sets in question. Instead, Medtronic is recommending that patients who notice anything unusual during the infusion set prime process immediately call the helpline for assistance and do not insert the infusion set.
If you have been injured as a result of a defective insulin pump or other defective medical device, contact the Chicago product liability attorneys at Ankin Law Office, LLC at (312) 600-0000 to learn more about a possible legal claim. After listening to the circumstances of your situation, we will conduct a thorough analysis of any possible legal claims. We will explain your legal rights to you so that you can make an informed decision about how to proceed, and we will vigorously advocate on your behalf to get you the compensation that you need and deserve.